| Primary Device ID | B201CGTPF0 |
| NIH Device Record Key | d19215aa-e537-4415-893c-79587befb852 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Clear Guide TP Access Frame |
| Version Model Number | CGTPF |
| Catalog Number | CG-TPF |
| Company DUNS | 965399905 |
| Company Name | CLEAR GUIDE MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| B201CGPAT0 - Clear Guide TP Access Tool | 2025-01-20 The device is a configurable, manual surgical aid accessory with multi-modality fiducial markers and a needle guide grid for ima |
| B201CGSCENERGYTP0 - Clear Guide SCENERGY TP | 2025-01-20 The Clear Guide SCENERGY is software that provides fusion of images from Computed Tomography (CT), Magnetic Resonance (MR), and |
| B201CGSG0 - Clear Guide SteriGRID | 2025-01-20 The device is a needle guide grid for image-guided transperineal procedures. The device is intended to guide needle placements d |
| B201CGTPF0 - Clear Guide TP Access Frame | 2025-01-20The device is a configurable, manual surgical aid accessory with multi-modality fiducial markers and a needle guide grid for image-guided transperineal procedures. The device is intended to guide needle placements while keeping the patient's perineum accessible during endorectal ultrasound and MR/CT-guided interventions. The device is intended for use in a clinical setting. The device is a guide frame replacement for the Clear Guide TP Access Tool (CG-PAT). |
| B201CGTPF0 - Clear Guide TP Access Frame | 2025-01-20 The device is a configurable, manual surgical aid accessory with multi-modality fiducial markers and a needle guide grid for ima |
| B201CGTPP0 - Clear Guide TP Access Posts | 2025-01-20 The device is a configurable, manual surgical aid accessory with multi-modality fiducial markers and a needle guide grid for ima |
| B201CGCORE170 - Clear Guide CORE | 2022-10-17 The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR G |
| B201CGCORE240 - Clear Guide CORE | 2022-10-17 The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR G |
| B201CGOHM0 - Clear Guide Optical Head | 2022-10-17 The device is intended as an accessory hardware to provide input into medical device software by capturing video and other senso |